| CTRI Number |
CTRI/2011/10/002074 [Registered on: 18/10/2011] Trial Registered Prospectively |
| Last Modified On: |
27/01/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative,Randomized Parallel group,Multicentric Prospective Phase III Clinical trial of FDC of Tolperisone Hcl SR 450mg+ Diclofenac sodium SR100mg tablet OD compared with Tolperisone Hcl 150mg tablet TID for 7 Days in Patients Suffering with Acute Non Specific Low Back Pain. |
|
Scientific Title of Study
|
Comparative,Randomized Parallel group,Multicentric Prospective Phase III Clinical trial of FDC of Tolperisone Hcl SR 450mg+ Diclofenac sodium SR100mg tablet OD compared with Tolperisone Hcl 150mg tablet TID for 7 Days in Patients Suffering with Acute Non Specific Low Back Pain. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEX/INV/CT-III/7730/15/05/10 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohan Pai |
| Designation |
Medical Director |
| Affiliation |
Mangalor Heart Centre |
| Address |
No.8, City Point, Kodialbail, Mangalore.
Bangalore
KARNATAKA
575003
India |
| Phone |
09845083135 |
| Fax |
|
| Email |
mohanpaik@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Bhatt |
| Designation |
President & CEO |
| Affiliation |
NEXUS CLINICAL RESEARCH (INDIA) LTD. |
| Address |
"Anuj", Plot No 45, 1st Floor, Sector-13, Near D.Y.Patil Stadium,
Mumbai-Pune Highway, Nerul-(East), New Mumbai- 400 706.
Maharashtra- India.
Raigarh
MAHARASHTRA
400706
India |
| Phone |
022-27714204 |
| Fax |
|
| Email |
dramit.bhatt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautam Saranath |
| Designation |
General Manager |
| Affiliation |
Inventia Healthcare Pvt Ltd. |
| Address |
Inventia Health care Pvt. Ltd.
505, VIP plaza,
Veera Industrial Estate, Link Road, Andheri (W),
Mumbai -400053.
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
91-9987547061 |
| Fax |
|
| Email |
gautam.saranath@inventiahealthcare.com |
|
|
Source of Monetary or Material Support
|
| Inventia Health care Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Inventia Health care Pvt Ltd |
| Address |
Inventia Health care Pvt. Ltd.
505, VIP plaza,
Veera Industrial Estate, Link Road, Andheri (W),
Mumbai -400053.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tarsem Motten |
Govt. Medical College & Hospital |
Registrar Department of Orthopedic
Govt Medical College & Hospital
Jammu
Jammu
JAMMU & KASHMIR |
09419101542
drtarsemmoten@yahoo.in |
| DR RAHUL NEHRA |
Hope Hospital |
200, W.K.ROAD, MEERUT (U.P).
Meerut
UTTAR PRADESH |
09837052678
rahulnehra2001@yahoo.co.in |
| Dr Kishor Kadu |
Jeevandeep Hospital |
Rajendra Colony-Prashant Nagar Road,
Amravati- 444606.
Amravati
MAHARASHTRA |
9822590918
drkishor.kadu@gmail.com |
| DR KMOHAN PAI |
MANGLORE HEART CENTER |
NO. 8, CITY POINT, KODIALBAIL,
MANGALORE- 575003.
Bangalore
KARNATAKA |
09845083135
mohanpaik@rediffmail.com |
| DR DEEPAK BHAMBE |
NARENDRA PRAKASH HEALTHCARE CENTER |
DA-3/A, MAIN SHAKAR PUR,
OPP NATHU SWEETS,
BEHIND POLICE BOOTH, LAXMINAGAR,
DELHI-110092.
New Delhi
DELHI |
09654807949
dr.deepakbhambe@gmail.com |
| DR VINOD KOLHE |
SHRIKRUPA FRACTURE & ACCIDENTAL HOSPITAL |
NEAR POLICE STATION,
AKOLA ROAD, AKOT.
Akola
MAHARASHTRA |
9881724232
drvkolhe@yahoomail.com |
| Dr Tanuraj Sirohi |
Sirohi Clinic |
Opp. Chetan Medical Complex,
Chippi Tank, Meerut.
Meerut
UTTAR PRADESH |
09837020820
trsirohi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Central Independent Ethics Comittee Clinical Research (India) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Non Specific Low Back Pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fixed Dose Combination of Tolperisone HCl SR + Diclofenac Sodium SR |
Fixed Dose Combination of Tolperisone HCl SR 450 mg + Diclofenac Sodium SR 100mg OD for seven days |
| Comparator Agent |
Tolperisone Hcl |
Tolperisone Hcl 150 mg tablet TID for seven days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Non specific low back pain with an acute episode of recent onset (48 hours) defined by average pain within the last 24 hours equal or more than grade 4 on the Visual Analogue Scale (VAS)
Low back pain of diagnosis category 1 (low back pain radiating no farther than the intergluteal fold) or 2 (low back pain radiating no farther than the knee), as defined by the International Paris Task Force on Back Pain
Willing to give written informed consent
|
|
| ExclusionCriteria |
| Details |
Low back pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorder.,
Low back pain of diagnosis category 3 (low back pain radiating beyond the knee, with no neurologic signs) or 4 (low back pain radiating to a precise and entire leg dermatome, with or without neurologic signs), as defined by the International Paris Task Force on Back Pain.
History of inflammatory arthritis of large joints.
History of seizure disorders.
History of malignant tumor.
Treatment with steroidal agents (including aspirin) during the two days prior to prospective inclusion, prolonged used of corticosteroids.
Treatment with NSAIDs or muscle relaxant or opioid analgesics within 3 days of admission.
Psychiatric or mental diseases.
Immune Compromised HIV.
Inclusion in another study in the past six months or previous inclusion in this study.
History of alcohol, drugs or narcotics abuse.
Recent history of violent trauma.
Constant progressive, non mechanical pain (no relief with bed rest).
Thoracic pain.
Patient systemically unwell.
Unexplained weight loss.
Widespread neurological symptoms (including Cauda equine syndrome).
Structural deformity.
Fever.
Clinical significant renal dysfunction defined by Creatinine 1.5µmol/L.
Clinically significant hepatic dysfunction defined by:
Total Bilirubin 2 µmol/L.
SGOT (AST) 1.5 U/L.
SGPT (ALT) 1.5 U/L.
Patients who have received other therapy (physiotherapy, physical manipulations, invasive intervention, acupuncture therapy.) within the last 48 hours.
Pregnancy, breast feeding or women of childbearing potential not using efficient contraception.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate the superiority of the SR of fixed - combination of a muscle relaxant, Tolperisone Hcl 450mg and non steroidal anti-inflammatory drug, Diclofenac sodium 100mg, over oral Tolperisone Hcl 150mg tablet as single drug therapy, on average pain and mobility within the last 24 hours in adults suffering from acute non specific low back pain with an episode of recent onset. |
DAY -1 DAY 1 DAY 4 DAY 7
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the safety of the oral FDC of Tolperisone Hcl + Diclofenac Sodium, to that of Tolperisone Hcl. |
DAY -1 DAY 1 DAY 4 DAY 7
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/10/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be conducted after obtaining written informed consent from the subjects. The subjects will undergo medical screening during pre-study visit (Visit 1). Screening will include complete clinical evaluation (medical history, physical examination, record of height, weight and vital signs). Female volunteers of child bearing capability will be subjected to a urine pregnancy test. Enrolled subjects will receive the medication for 4 days (visit 2), at visit 3 efficacy and ADR evaluation will be done. At day7 (visit 4) end of therapy efficacy, safety, tolerability and ADR monitoring will be done. Subjects are allowed to visit to investigator at any time point during the study. |